MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; DYB INTRODUCER, CATHETER

Catalog Number	C-CAE-14.0-70-FIC
Medical Device Problem Codes	Flaked (1246); Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).A1) unknown as information was not provided.A2) unknown as information was not provided.A4) unknown as information was not provided.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.G5) similar to device under 510(k) e597079.(b)(4).Summary of investigational findings: investigation is based on description of event and returned product.Flaked areas were noted on both introducers: one had a flaking area close to one of the holes and the other had a flaking area ~3cm proximal to the holes.According to the rep."the customer has been made aware that the frova introducer is designed for placement of a single lumen tube - and not a double lumen tube as reported in this case." no evidence to suggest product was not manufactured to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: double lume tube has been introduced via frova.Splinters came of frova.Have been retrieved via bronchoscope.Patient outcome: the patient did require additional procedures due to this occurrence.The product caused or contributed to the need for additional procedures.Splinters could be removed without any further consequences.No adverse effects on the patient due to this occurrence.

• Brand Name: FROVA INTUBATING INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 6452639
• Report Number: 3002808486-2017-00878
• Device Sequence Number: 18948031
• Product Code: DYB
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)141123(10)E2836104
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/17/2012
• Device Age: 4 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2012
• Initial Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention